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FDA 510(k)

Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E

K-Number: K163041 · 2017-02-22

ApplicantPt. Medisafe Technologies
Decision Date2017-02-22
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E is a medical device manufactured by Pt. Medisafe Technologies. It received FDA 510(k) clearance on 2017-02-22 under approval number K163041. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E?

Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E is a medical device that received FDA 510(k) clearance on 2017-02-22. It is manufactured by Pt. Medisafe Technologies. The 510(k) number is K163041.

When was Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E approved by the FDA?

Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E received FDA 510(k) clearance on 2017-02-22, under approval number K163041.

What company makes Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E?

Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E is manufactured by Pt. Medisafe Technologies.

What is the FDA product code for Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E?

The FDA product code for Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E is LZA.

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Other Devices by Pt. Medisafe Technologies

K173258Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy K182176Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs K201774Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs

Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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